Executive Medical Director, Clinical Development, Solid Tumors

About the Company

Founded in 1886 in Naples as Farmacia Internazionale and relocated to Florence in 1915, Menarini Group is an Italian pharmaceutical company with nearly 135 years of history. The company operates in 140 countries across Europe, Asia, Africa, the Middle East, Central America, and the United States. Menarini employs around 18,000 people and produces over 500 million packs of drugs annually across 18 manufacturing sites, including a biotech plant for monoclonal antibodies.

Menarini is committed to oncology, with a pipeline of five investigational compounds for hematological and solid tumors. The acquisition of Stemline Therapeutics in 2020 strengthened its oncology portfolio, adding commercial and clinical-stage assets such as ELZONRIS® (tagraxofusp), the first approved treatment for blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the U.S. and EU, and ORSERDU™ (elacestrant), the first treatment for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. Menarini also commercializes Nexpovio®, a first-in-class oral exportin 1 (XPO1) inhibitor for multiple myeloma.

Through its affiliate Menarini Silicon Biosystems (MSB), the company invests in liquid biopsy diagnostics, offering advanced solutions like the CELLSEARCH® Circulating Tumor Cell (CTC) Test, the first FDA-cleared blood test for detecting CTCs in metastatic breast, prostate, and colorectal cancers. MSB also provides non-invasive Laboratory Developed Tests (LDTs) for cancer patient monitoring.

Responsibilities

• Drive the global clinical development strategy for solid tumors, focusing on Stemline’s Breast Cancer product, Elacestrant.
• Provide critical input into the strategy, development, management, and implementation of Phase 1-4 clinical studies in collaboration with Clinical Operations colleagues.
• Lead multi-disciplinary teams to guide clinical development and regulatory submissions, including first-in-human through registration-enabling studies.
• Represent the clinical science function on global program teams and contribute to strategic planning and execution of the clinical development plan.
• Develop clinical study protocols, amendments, study guides, training materials, and other related documents based on the global development plan.
• Perform medical monitoring, including safety data review, signal identification, and responses to site inquiries, collaborating with CRO medical monitors as needed.
• Take medical responsibility for data analysis, interpretation, reporting, and communication to ensure consistency across Clinical Study Reports, health authority briefing books, and NDA/BLA submissions.
• Contribute to operational aspects of study conduct, including site training, initiation, activation, and patient enrollment efforts.
• Maintain focus on robust study conduct and high-quality data generation.
• Develop innovative clinical strategies to shorten the development cycle amid an evolving regulatory landscape.
• Oversee Phase I–III clinical development of products and may supervise Medical/Scientific Directors and Clinical Scientists.
• Act as the clinical lead, engaging with key opinion leaders, regulatory agencies, and advisors.

Requirements

• Medical Degree with 7+ years of pharma/biotech experience.
• Board certification in oncology and/or oncology training strongly preferred.
• Experience developing clinical strategy for oncology products (Phase I-III) leading to successful regulatory submissions.
• Training or experience in Breast Cancer and developing Breast Cancer compounds within the industry.
• Expertise in clinical trials, including statistical principles, medical monitoring, literature research, and authoring clinical trial publications.
• Working knowledge of GCP, ICH, FDA, and EMEA regulations.
• Excellent written and verbal communication skills for all organizational levels.
• Ability to work cross-functionally with Regulatory, Medical Affairs, Statistics, PK/PD, Commercial, HEOR, and other teams.
• Experience interacting with investigators, KOLs, regulatory agencies, and advisors.
• Proficiency in data analysis, interpretation, and clinical relevance.
• Solid knowledge of compliance and global regulatory requirements for pharmaceutical development.
• Proven ability to represent company interests in interactions with partners and regulatory agencies.
• Leadership in a dynamic, fast-paced environment with a focus on scientific rigor and creative solutions.
• Ability to develop and implement strategic growth plans.
• Comfort with ambiguity while being self-motivated and timeline-driven.

Pay

Base Salary Range: $285,000 - $395,000 (plus bonus and Long-Term Incentive package).

Benefits

• Short- and Long-Term Incentive Programs.
• Fidelity 401(k) with a 6% company match.
• Anthem Premier PPO and HDHP insurance plans.
• Company-paid Basic Life & AD&D insurance.
• Pre-tax FSA/HSA programs.

This position is classified as a corporate office role. Under the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of work location.